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Lack of discrepancy review nets drug firm 4-item 483.(HUMAN DRUGS)
Inspection Monitor
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July 1, 2008
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Altaire Pharmaceuticals, Aquebogue, NY, Jamaica, NY, District
Altaire Pharmaceuticals, Aquebogue, NY, received a four-item 483 for allegedly failing to review any unexplained discrepancy whether or not the batch had already been distributed. Investigator James Liubichich from the Jamaica, NY, District Office conducted the audit.
Only the 483 was available at press time. Specifically, one of the firm's investigations was assigned on Feb. 21, 2007, yet no report had been written as of June 25, 2007. Also, another investigation was assigned on April 30, 2007, ...
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